BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MDElite iProX

    DI: 00860007876806 · Model: iProX · MDElite Laser and Aesthetic, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MDElite iProX
    Primary DI
    00860007876806
    Version / Model
    iProX
    Company Name
    MDElite Laser and Aesthetic, LLC
    Labeler DUNS
    118440103
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-25
    Public Version
    2
    Public Version Date
    2023-10-23
    Public Version Status
    Update
    Public Device Record Key
    53d5865e-c9a5-426b-a395-5fec6d5943d2

    Device Description

    MDElite iProX - Intense Pulsed Light Equipment - AC110V 50/60Hz 2500VA 34*57*118cm 62kg - FDA 510(k) K193328

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    58935 Intense pulsed light skin surface treatment system

    Identifiers

    Type ID
    Primary 00860007876806